| CTRI Number |
CTRI/2020/11/029223 [Registered on: 19/11/2020] Trial Registered Prospectively |
| Last Modified On: |
31/03/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparative evaluation between two anti inflammatory drugs ibuprofen and mefenamic acid in reduction of preoperative and post operative endodontic pain. |
|
Scientific Title of Study
|
Double-blind Randomized controlled Trial of Efficiency of Nonsteroidal
Anti-inflammatory Drugs, Ibuprofen and Mefenamic acid in the Control of peroperative and postoperative endodontic pain.
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shweta Santosh Lodha |
| Designation |
post graduate student |
| Affiliation |
ACPM Dental college |
| Address |
ACPM Dental college. Department of conservative dentistry and Endodontics. post graduate section, room no 4.
ACPM Dental college. Department of conservative dentistry and Endodontics. Post graduate section, room no 4.
Dhule
MAHARASHTRA
424001
India |
| Phone |
8830403762 |
| Fax |
|
| Email |
sllodhashweta@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shweta Santosh Lodha |
| Designation |
post graduate student |
| Affiliation |
ACPM Dental college |
| Address |
ACPM Dental college. Department of conservative dentistry and Endodontics, postgraduate section, room number-4.
sakri road, Dhule, Maharashtra.
ACPM Dental college. Deparment of conservative dentistry and Endodontics, postgraduate section, room number -4
sakri road, Dhule, Maharashtra.
Dhule
MAHARASHTRA
424001
India |
| Phone |
8830403762 |
| Fax |
|
| Email |
sllodhashweta@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shweta Santosh Lodha |
| Designation |
post graduate student |
| Affiliation |
ACPM Dental college |
| Address |
ACPM Dental college. Department of conservative dentistry and Endodontics, postgraduate section. room number-4
sakri road, Dhule, Maharashtra.
ACPM Dental college.Department of conservative dentistry and Endodontics, postgraduate section. room number-4 sakri road, Dhule, Maharashtra.
Dhule
MAHARASHTRA
424001
India |
| Phone |
8830403762 |
| Fax |
|
| Email |
sllodhashweta@gmail.com |
|
|
Source of Monetary or Material Support
|
| ACPM Dental college Dhule, Department of conservative dentistry and endodontics. |
|
|
Primary Sponsor
|
| Name |
Dr kavita rudagi |
| Address |
ACPM Dental college Dhule. Department of conservative dentistry and Endodontics. room number 4. |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| self |
ACPM Dental college dhule |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| kavita rudagi |
ACPM Dental college |
ACPM DENTAL COLLEGE, SAKARI ROAD, DHULE, MAHARASHTRA
Dhule
MAHARASHTRA |
9673390777
kavita.rudagi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ACPM Dental college |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K040||Pulpitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
meftal forte |
mephenemic acid(500 mg)
single dose, once daily, oral route of administration.
total duration of therapy for single individual patient is one day |
| Intervention |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1)Patient having Spontaneous pain
2)Patient with Pain of endodontic origin.
3)No apparent periapical lesion according to radiographic image.
4)Presented with American Society of Anesthesiologists I or II medical history
5)Read and understood the pain score level sheet
|
|
| ExclusionCriteria |
| Details |
1)Patient younger than 15 years of age.
2) Analgesic taken within last 6 hrs.
3)Pregnant and lactating patients.
4)History of allergy to NSAIDs, aspirin or local anesthetic.
5)History of various systemic diseases.
6)Patient currently taking opioids, monoamine oxidase inhibitors, tricyclic antidepressant.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| reduction in pain noted |
8 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| mepheemic acid shows good analgesic effect |
8 hours |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
25/11/2020 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="30" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
Modification(s)
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
The present clinical trial aimed to compare and evaluate the effectiveness of ibuprofen and mefenamic acid on preoperative and postoperative endodontic pain. Methods: The inclusion criteria are moderate to severe pain of irreversible pulpitis, by using the Visual analogue scale, on mandibular molar teeth, as well as the absence of signs and symptoms of any periapical lesion. two drugs will be compared, the ibuprofen group will receive single dose of combine ibuprofen/paracetamol and mefenamic acid group will receive single dose of combine mefenamic acid/paracetamol. Pain intensity will be measured using visual analogue scale, preoperatively, at one hour after administration of analgesic followed by single visit root canal treatment and measurement of pain intensity at 2 hour and 6 hour. |